INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics, a leading biopharmaceutical company, will host a virtual R&D day on November 10, 2020, featuring two sessions: one in Mandarin from 8:00 AM to 12:00 PM and another in English from 9:00 PM to 1:00 AM (next day), both China/Singapore time. The event will cover the company's development, long-term vision, and an in-depth discussion on its R&D pipeline. Participants must register before November 8 to receive access details. Innovent is recognized for its innovative treatments, including three marketed products and a robust pipeline targeting major diseases.

Innovent Biologics announced that the ORIENT-32 Phase 3 trial of TYVYT® (sintilimab injection) combined with BYVASDA® (bevacizumab biosimilar injection) for treating advanced hepatocellular carcinoma met primary endpoints of progression-free survival (PFS) and overall survival (OS). This interim analysis showed significant improvements over sorafenib, with a safety profile consistent with prior studies. Innovent plans to discuss these results with the National Medical Products Administration in China to potentially advance treatment options for HCC patients.

Innovent Biologics and Eli Lilly presented biomarker results from the ORIENT-11 study at the ESMO Virtual Congress 2020. The trial evaluated TYVYT® (sintilimab injection) combined with ALIMTA® (pemetrexed) for first-line treatment of advanced nonsquamous non-small cell lung cancer (nsqNSCLC). Biomarker analysis indicated that the MHC-II pathway is linked to better progression-free survival (HR, 0.41; P=0.0041), suggesting its potential as a predictive marker. The Chinese NMPA has accepted a supplemental NDA for this combination therapy, indicating a significant step in cancer treatment advancements.

Innovent Biologics and Eli Lilly presented results from the ORIENT-12 study at the ESMO Virtual Congress 2020. This Phase 3 trial evaluated TYVYT® (sintilimab injection) combined with GEMZAR® and platinum chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sqNSCLC). The study enrolled 357 patients and showed a significant improvement in progression-free survival (PFS) with TYVYT® compared to placebo. The median PFS was 5.5 months for the treatment group versus 4.9 months for placebo, indicating a promising clinical outcome with no new safety signals reported.

Innovent and Eli Lilly announce the presentation of six clinical studies for TYVYT® (sintilimab injection) at the upcoming ESMO Virtual Congress 2020 from September 19-21. Key studies include Phase 3 trials for lung cancer and hepatocellular carcinoma, showing positive preliminary efficacy. Innovations include the combination of sintilimab with various chemotherapy agents, providing insights into patient selection and treatment outcomes. The collaboration between Innovent and Lilly emphasizes a strong partnership in advancing oncology treatments.

Innovent Biologics has received approval from China's National Medical Products Administration for SULINNO® (adalimumab injection), a biosimilar treatment aimed at rheumatoid arthritis, ankylosing spondylitis, and psoriasis. This marks Innovent's third monoclonal antibody approval, expanding its product range beyond oncology. With around 20 million patients in China suffering from these conditions, SULINNO® aims to offer a more affordable alternative to existing therapies, thus improving access and quality of life for patients.

Innovent Biologics has announced the completion of first healthy subject dosing in its Phase I clinical trial (CIBI112A101) for IBI112, a recombinant anti-interleukin 23p19 subunit antibody. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and tolerability of IBI112 in healthy Chinese subjects. IBI112 targets IL-23, playing a pivotal role in autoimmune diseases such as psoriasis and inflammatory bowel disease. Innovent aims to address significant unmet medical needs in these conditions, with promising preclinical data supporting the drug's efficacy and safety.

Innovent Biologics reported the successful presentation of Phase 1 and Phase 2 clinical study results for Tafolecimab (IBI306) at the European Society of Cardiology conference. The monoclonal antibody demonstrated a satisfactory safety and efficacy profile, with LDL-C reduction rates reaching -52.2% to -72.1% in healthy subjects and -54.30% to -72.26% in hypercholesterolemic patients. Tafolecimab, recognized as a domestically developed PCSK9 inhibitor, offers a longer dosing interval compared to existing treatments, thereby presenting a promising option for patients with high cardiovascular risks.

Innovent Biologics reported a significant revenue increase of 184.9% in H1 2020, totaling RMB984.2 million, driven mainly by TYVYT® sales at RMB920.9 million. The company launched BYVASDA®, its second commercial product, and received approval for strategic drug applications. Collaborations with Roche and Eli Lilly are pivotal, particularly with a US$1 billion agreement for TYVYT® outside China. However, gross profit margins slightly decreased to 81.2%. Despite RMB608.2 million in losses, cash reserves stand strong at US$875 million.